NCT00955786已完成1 期
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety and Tolerance, and Pharmacokinetic Study of Intravenously Administered CX-3543,on a Daily x 5, Repeated Every 3 Weeks Schedule, in Patients With Advanced Solid Tumors or Lymphomas
Cylene Pharmaceuticals0 个研究点目标入组 48 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
研究概览
简要总结
This phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
详细描述
CX-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. This drug was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.This Phase 1 study of CX-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed solid tumors or lymphomas.
- •Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
- •One or more tumors measurable on radiograph or CT scan, or evaluable disease. (e.g., malignant ascites)
- •Karnofsky performance status of greater than or equal to
- •Life expectancy of at least 3 months.
- •Age at least 18 years.
- •Patients must have central IV access, or agree to the insertion of a central IV line.
- •A negative urine pregnancy test (if female.)
- •Acceptable liver function as evaluated by laboratory results
- •Acceptable hematologic status as evaluated by laboratory results
- •No clinically significant urinalysis abnormalities
- •Acceptable coagulation status as evaluated by laboratory results
- •Fertile men and women must use effective contraceptive methods during the study.
排除标准
- •Seizure disorders not controlled by anticonvulsant therapy.
- •Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months.)
- •Severe chronic obstructive pulmonary disease with hypoxemia or a pulmonary compromise not correctable with therapy.
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
- •Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- •Pregnant or nursing women.
- •Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C.)
- •Unwillingness or inability to comply with procedures required in this protocol.
- •Known infection with HIV, hepatitis B, or hepatitis C.
- •Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
- •Patients who are currently receiving any other investigational therapy.
- •Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.
研究组 & 干预措施
CX-3543
Experimental
干预措施: CX-3543 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
时间窗: Cycle 1
Recommended Phase 2 dose
时间窗: Cycle 1
次要结局
- Pharmacokinetics (PK) in humans of intravenously administered CX-3543.(Monthly)
- Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment.(Every two months)
- Pharmacodynamic evaluation of antitumor activity(Monthly)
研究者
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